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February 5, 2026
Approximately 5 minutes
Clinical Evaluation and Investigations for Medical Devices in Finland
Clinical Evaluation and Investigations for Medical Devices in Finland
1. Overview of Clinical Investigations
Clinical investigation is any systematic investigation involving human subjects to assess safety or performance of a medical device, per Regulation (EU) 2017/745 (MDR). Requirements in Chapter I of Annex XV apply to all investigations. Fimea must be notified of all clinical investigations; most require authorisation, some notification. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
2. Types Requiring Authorisation or Notification
- Article 62: Authorisation required for non-CE marked devices or CE-marked outside intended purpose, if results used in conformity assessment.
- Article 82: Authorisation for other investigations (e.g., investigator-driven with CE-marked devices).
- Article 74(1): Notification for PMCF with additional invasive/burdensome procedures. Guidance: MDCG 2021-6 on regulatory pathways. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
3. Submission to Fimea
Use MDCG 2021-08 application form. Submit electronically via secure mail to clinicaltrials@fimea.fi or post. Supporting documents per checklists; must include ethics committee opinion. Documents in Finnish, Swedish, or English; key summaries in Finnish/Swedish. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
4. Processing and Deadlines
Validation phase followed by assessment. Deadlines per MDR Articles 70-71 and national law. Investigation may start after authorisation (or validation for certain cases) and no negative ethics opinion. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
5. Modifications, Adverse Events, and Reporting
Substantial modifications: Notify within one week using MDCG 2021-28 form. Adverse events: Report per MDCG 2020-10/1. Termination/halt: Notify within 15 days (24 hours if safety grounds). Final report: Within one year of end (three months for early termination), with lay summary. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
6. Fees and Additional Guidance
Fees per Fimea decree. National law: Medical Devices Act 719/2021 and Administrative Regulation 1/2022. Ethics: National Committee on Medical Research Ethics (Tukija). Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
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